Patients with rheumatoid arthritis (RA) in Europe are a giant step closer to receiving access to a subcutaneous formulation of Roche/Chugai's RoActemra, following the thumbs up from the European Medicines Agency's advisory group.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of RoActemra for the treatment of moderate to severe active RA in patients who have either responded inadequately to, or who are intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) inhibitors.
If the EMA follows its advice and issues a green light for the drug, RoActemra would be the first IL-6 biologic available in subcutaneous and intravenous administration for both monotherapy and combination therapy, the firms noted.
Unlike its intravenous sister product, subcutaneous RoActemra - delivered under the skin via a prefilled syringe and a prefilled pen - will offer patients the potentially more convenient option of treatment administration in the home.
The CHMP’s positive opinion came on the back of data from the Phase III SUMMACTA and BREVACTA studies, demonstrating its efficacy and tolerability.
The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, elevated blood pressure, and increased liver enzyme, while the most serious adverse reactions observed include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis, the groups said.